[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589504":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":10,"enrollmentInfo":72,"targetDuration":10,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Corsano Health B.V.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: patients receiving 24-48 hour holter monitoring as standard of care",null,"Holter monitoring will be compared to continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to an ECG-holter reference across various demographic groups. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's with the investigational device at standard timepoints (every 2 hours when awake), and when AF is detected (minimal 30 minutes time difference between alerts) across the 24-48 hours.",[13],"Device: Corsano CardioWatch 287-2",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up","Patients with a known diagnosis of (paroxysmal) atrial fibrillation presenting to the clinic for routine follow-up evaluation will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A, these patients will also be asked to perform manual ECG measurements with the investigational device. Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NCT05899959) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation","Patients with a known diagnosis of (paroxysmal) atrial fibrillation registered in a patient organisation for patients with AF will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A and B, these patients will also be asked to perform manual ECG measurements with the investigational device. For this group two (virtual) visits will be scheduled before (visit a) and after (visit b) the study period. In visit a) additional information regarding the study will be provided and potential alarm signals will be screened to ensure the patient does not participate in the trial in case direct medical attention is required. If the patient does not show any alarm signals they will be asked to provide informed consent. Once informed consent is provided all materials will be mailed to them via postal services after which they can perform the measurements and return the materials via postal",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.","Participants in this group will wear the CardioWatch 287-2 during the standard 12-lead ECG recordings conducted in the outpatient clinic. Patients will be asked to perform a manual ECG spot-check with the investigational device during (if not feasible directly before), and immediately following the 12-lead ECG. Furthermore, the CardioWatch 287-2 will be worn for at least 5 minutes prior to and following the 12-lead ECG. Although these recordings are brief, this group was included to enhance the study population's size and demographic diversity while minimizing the burden on both patients and hospital staff. This group is expected to consist of both non-AF and AF patients, providing valuable insights into the investigational device's performance in a setting similar to its intended real-world application.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","Corsano CardioWatch 287-2","Patients receive monitoring of their heart rhythm by the CardioWatch 287-2 next to monitoring of their heart rhythm by either a 24-48 holter or a short in-clinic 12-lead ECG monitoring.",[9,15,19,23],[33],{"name":34,"affiliation":35,"role":36},"Eelko Ronner, MD, PhD","Reinier de Graaf Groep","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","015-2603320","+31","eronner@rdgg.nl",[44],{"facility":45,"status":10,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Reinier de Graaf Gasthuis","Delft","South Holland","2625AD","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],4.35556,52.00667,{"lat":55,"lon":54},[58],{"name":34,"role":39,"phone":59,"phoneExt":41,"email":42},"015 - 260 33 20",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100589504","multi-centre-based-study-recognition-of-atrial-fibrillation-with-the-corsano-cardiowatch-287-2-system-100589504",false,"NCT06955273","Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System","COR-AF","Inclusion Criteria:\n\n* Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation\n* Age ≥ 22 years old\n* Able to provide informed consent.\n* Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.\n\nExclusion Criteria:\n\n* Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;\n* Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;\n* Unable or not willing to receive ECG monitoring;\n* Unable or not willing to sign informed consent;",true,"ALL","22 Years",{"count":73,"type":74},350,"ESTIMATED","OBSERVATIONAL","This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.\n\nTo ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited:\n\n* Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring\n* Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.\n* Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.\n* Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.\n\nThe secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.",[78,79],"Atrial Fibrillation (AF)","Paroxysmal Atrial Fibrillation (PAF)",[81,82,83,84,85,86,87],"wristband","wearable","atrial fibrillation","holter","ecg","remote monitoring","validation","NOT_YET_RECRUITING","2025-04-30",{"date":91,"type":92},"2025-05-02","ACTUAL",{"date":94,"type":74},"2025-05-01",{"date":96,"type":74},"2026-01",{"name":5,"class":6},1]